Questions and Answers for NIH’s HIV/AIDS Clinical Trials Network LOC, LC, and SDMC FOAs

Updated July 16, 2019. We added one new question about ongoing clinical studies in the Study and Trial Issues section.

NIAID has released six Funding Opportunity Announcements (FOAs) related to the NIH HIV/AIDS Clinical Trials Networks:

The questions and answers shown below are for those six FOAs.

We also published the FOA for HIV/AIDS Clinical Trials Units, RFA AI-19-045, on May 1, 2019. See the separate Questions and Answers for NIH’s HIV/AIDS Clinical Trials Units FOA, RFA-AI-19-045.

Learn more about NIH’s HIV/AIDS Clinical Trials Networks on the main webpage, Refining the HIV Clinical Trials Enterprise.

Table of Contents

General

Will NIAID post additional questions and answers or revise the current ones?

Each time we add new questions or revise, we will replace the dated note shown at the top of this page.

Do these questions and answers modify or add instructions?

No, these questions and answers do not modify or add any instructions. These answers are intended to help you understand and follow the instructions in the RFAs.

Are these FOAs limited to previous network grantees?

No. This is not a limited competition. New and renewal applications are welcome.

What is a UM1 and how is a UM1 application structured?

NIH uses the UM1 activity code to support cooperative agreements involving large-scale research activities with complicated structures that cannot be appropriately categorized into an available single component activity code. A UM1 application is structured as a single application with multiple elements representing a variety of supporting functions.

The Leadership and Operations Center (LOC), Statistical and Data Management Center (SDMC), and Laboratory Center (LC) FOAs are separate. How do the SDMC and LC applications address the research agenda that will be included in the applications in response to the LOC FOA?

The SDMC and LC applications should describe their capability and how they will advance the research priority areas for the network they propose to support.

Are foreign institutions allowed to apply to the LC, LOC, and SDMC FOAs?

No. The sponsoring institution must be a U.S. (domestic) institution. However, foreign components are allowed in the application.

Are there any specific level of effort requirements for the PD/PI of the LOC application?

If you propose a single PD/PI, the PD/PI must devote at least 6 person-months of effort to the project. If you name two or more PD(s)/PI(s), each PD/PI must devote at least 3.6 person-months of effort to the project.

The FOA says “Do not name or contact potential collaborators that are not already key personnel in the application or are not providing a letter of support.” Would you clarify who we can name or contact?

In your application, name personnel and collaborators that have committed to serving a role (e.g., key personnel, those providing a specific service documented by a Letter of Support). Do not name or contact groups or individuals as examples of resources that potentially could provide a service or as examples of personnel who are appropriate for a role.

What types of letters of support can I include?

Provide appropriate letters of support limited to collaborators who have a significant role in the application. Note that letters establishing intra-network and cross-network collaborations are not necessary.

May an institution submit more than one application in response to the LC and SDMC FOAs?

NIAID plans to fund one LC award for each network and one SDMC award for each network.

A sponsoring institution may submit more than one application in response to the LC FOA and more than one application in response to the SDMC FOA. However, each application must address the research priority areas of only one HIV/AIDS Clinical Trials Network. Applications addressing the research priority areas of more than one HIV/AIDS Clinical Trials Network will be considered non-responsive and will not be reviewed.

For example, Institution X could submit one SDMC application to support the HIV/AIDS Adult Therapeutics Clinical Trials Network and a second SDMC application to support the HIV/AIDS Maternal, Adolescent and Pediatric Therapeutics Clinical Trials Network. But Institution X cannot submit a single application to be the SDMC for both the HIV/AIDS Adult Therapeutics Clinical Trials Network and the HIV/AIDS Maternal, Adolescent and Pediatric Therapeutics Clinical Trials Network. Institution X can also submit more than one application to be the SDMC to support the research priority areas for an individual network.

Each application is required to stand alone and will be reviewed independently.

This response also applies to the LC FOA.

What “Other Attachments” must I include in the Leadership and Operations Center application and where do I add these attachments?

Each LOC application must include the following 4 attachments as PDF files. They must be added under the “Other Project Information” as explained in the SF424 Application Guide:

Attachment 1. Quality Management Plan
Provide a full LOC Quality Management Plan including quality control, quality assurance and quality improvement. If appropriate, provide an example protocol-specific Quality Plan for a protocol opened for enrollment since July 2018 (use filename "Quality Management Plan").

Attachment 2. Sample Protocol Template
Provide a sample protocol template (use filename "Protocol template").

Attachment 3. Procedures for Clinical Site Selection
Provide procedures for the selection of clinical sites (use filename "Clinical Site Selection").

Attachment 4. Procedures for Clinical Site Performance Evaluation
Provide procedures for clinical site performance evaluation, including how poor performance will be defined, and if appropriate, how it will be addressed (use filename "Clinical Site Performance").

There are no page limits for the attachments. Include only information relevant to the topic in these attachments.

For RFAs AI-19-003, AI-19-004, AI-19-005, and AI-19-006 (LOCs), should applicants include all clinical research sites in the performance site list?

These FOAs solicit applications for Clinical Trials Network Leadership and Operations Centers (LOCs). We issued a separate FOA for Clinical Trials Units (CTUs) which includes Clinical Research Sites (CRSs).

Noting the specific LOC responsibilities as outlined in the FOAs and noting that protocol funding (PF) will be determined and provided post award through a collaborative process with NIAID, applicants should only list proposed performance site locations where the work described in the LOC Research Plan will be conducted (i.e., to support the core functions of the LOC).

(Question and answer above added on March 28, 2019.)

Specific to Part 2 Section IV of the FOAs, are we able to cross-reference sub-sections when related information is requested? Will individual sub-sections be separated out and reviewed by different reviewers?

Although there are related topics across sub-sections, the FOA instructions do not require applicants to provide redundant responses or information. Assigned peer reviewers will be asked to review the entire application and not just individual sub-sections. Therefore, cross-referencing information across sub-sections is acceptable.

(Question and answer above added on April 10, 2019.)

Are page limits a guiding principle with an overall limit, or are individual sub-sections strictly limited to what the FOA states for each sub-section?

Page limits for individual sub-sections are strictly limited. Review the FOA instructions: “All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed with the following additional instructions: the Research Strategy must consist of the following sub-sections with the indicated page limits.” Space saved in one sub-section cannot be applied to another sub-section.

(Question and answer above added on April 10, 2019.)

Is the progress report I submit with my competing renewal application in response to the RFA sufficient to meet the progress report requirement for the last year of my current award, due October 1, 2019? If not, what portion of the progress report should be included in the response to the RFA?

For current awards, the annual Research Performance Progress Report (RPPR) should include the information described in the RPPR instructions. The RPPR should be submitted by the due date, October 1, 2019.

Section IV (Application and Submission Information) instructions under “PHS 398 Research Plan” for RFAs AI-19-001, AI-19-002, AI-19-003, AI-19-004, AI-19-005, and AI-19-006 state the following: “For renewal applications: Progress Report should be included in sub-section A.” The progress report to be included in the competing renewal application is due August 1, 2019 with the application submission.

The NIH How to Apply - Application Guide offers the following instructions under Research Strategy:

Progress Report for Renewal and Revision Applications:

Note that the Progress Report falls within the Research Strategy and is therefore included in the page limits for the Research Strategy.

For renewal/revision applications, provide a Progress Report. Provide the beginning and ending dates for the period covered since the last competitive review. In the Progress Report, you should:

  • Summarize the specific aims of the previous project period and the importance of the findings, and emphasize the progress made toward their achievement.
  • Explain any significant changes to the specific aims and any new directions, including changes resulting from significant budget reductions.
  • Discuss previous participant enrollment (e.g., recruitment, retention, inclusion of women, minorities, children, etc.) for any studies meeting the NIH definition for clinical research. Use the Progress Report section to discuss, but not duplicate information collected elsewhere in the application.

Do not include a list of publications, patents, or other printed materials in the Progress Report. That information will be included in the "Progress Report Publication List" attachment.

(Question and answer above added on May 28, 2019.)

Can you clarify what should be included in the Progress Report for renewal applications?

Refer to the question and answer, “Is the progress report I submit with my competing renewal application in response to the RFA sufficient to meet the progress report requirement for the last year of my current award, due October 1, 2019? If not, what portion of the progress report should be included in the response to the RFA?”

(Question and answer above updated on May 28, 2019.)

For RFA AI-19-002 (SDMCs), the “Letters of Support” section asks applicants to include a letter from the applicant organization(s) describing the role of institutional support of the following:

  • negotiation and execution of subcontracts, and other legal agreements including but not limited to software licenses, cloud data services, hardware, direct electronic data capture process, specimen tracking, negotiation of data use agreements, and system validation processes.

Can you provide any details about what is expected? How does this information differ from what is required in the “Facilities and Other Resources” section?

Institutional resources may be described in the Facilities & Other Resources section of the application. Letter(s) of Support offer the opportunity to document institutional understanding, flexibility, and readiness to support the program. The nature and level of institutional commitment should be commensurate with the scale and complexity of the grant application and reflect the specific needs of a complex network requiring negotiation and execution of multiple complex subcontracts and other legal agreements.

For this FOA, specific attention is needed regarding institutional support for IT systems and related data and regulatory support issues. Applicants may decide how to most effectively document the nature and level of institutional support by the choice of individuals/departments providing letters and the specifics of the commitments.

(Question and answer above added on May 28, 2019.)

I won’t be able to submit my application on time. May I have permission to submit a late application?

No matter how reasonable the excuse is, we do not have authority to grant advance permission for late submissions. Refer to Late Applications for additional details.

(Question and answer above added on July 8, 2019.)

We are getting an error, warning, or technical issue when we try to submit our application. What should we do?

Your application must pass validations at the Grants.gov and eRA Commons with no errors. If an error message describes an issue in the application, Submit a Changed/Corrected Application before the deadline. Warnings won’t stop your application, but you may wish to address them in the same way. Learn more about errors and warnings at NIH’s Submit, Track, and View Your Application.

If you encounter an error you are unable to resolve or technical System Issues, contact the help desk for the system in question:

(Question and answer above added on July 8, 2019.)

A system issue is preventing me from submitting my application. Help!

Please contact the eRA Commons Service Desk for assistance.

(Question and answer above added on July 8, 2019.)

Where do I find information about other grant application submission issues?

Please refer to Submission Policies.

(Question and answer above added on July 8, 2019.)

Scientific Focus and Structure

What types of clinical research can be supported by the Networks?

The emphasis of each network is on development and implementation of NIH-defined clinical trials. Clinical research studies that aren’t NIH-defined clinical trials are also in scope when needed to support the program. Read NIH’s How can researchers determine whether a proposed study is a clinical trial?

Some of the identified research priority areas are described as requiring “cross-network collaborations.” Can you clarify what this means for priority areas such as passive administration of antibodies, pediatric HIV vaccines, and TB vaccines?

Some of the research priority areas require expertise and/or capacity that crosses networks. For instance, research related to passive administration of antibodies will continue to be at the scientific interface of HIV vaccine- and non-vaccine prevention. Accordingly, we expect both the HIV Vaccines and HIV Prevention Networks to collaborate and provide joint scientific leadership in this area.

We expect the HIV Vaccines Network to lead pediatric HIV vaccination efforts once candidate vaccines are determined to be safe and sufficiently efficacious in adults. We expect the Maternal, Adolescent and Pediatric Therapeutics Network to provide collaborative support to the Vaccines Network.

The evaluation of TB vaccines is a research area that requires expertise across clinical trial networks. We expect the HIV Vaccines Clinical Trials Network to provide scientific leadership for TB vaccine clinical trials that evaluate vaccine immunogenicity and use in the prevention of TB infection in adults, adolescents, and children. However, for trials assessing vaccines for prevention of disease, prevention of recurrence, and therapeutic vaccine trials in adults in which diagnosis and management of clinical disease is necessary, the Adult Therapeutics Clinical Trials Network will take the lead for adult populations with collaborative support from the HIV Vaccines Clinical Trials Network. For trials assessing vaccines for prevention of disease in pediatric populations, the Maternal, Adolescent and Pediatric Therapeutics Clinical Trials Network will take the lead with collaborative support from the HIV Vaccines Clinical Trials Network.

Would an application proposing topical agents be responsive to the HIV Prevention LOC FOA?

As the LOC applicant establishes the priorities and plans within their application, they must consider the types of HIV prevention concepts that they will evaluate. Experience has shown that adherence to daily and on demand concepts is quite variable. For the purposes of this application, the LOC leadership needs to define their decision-making process considering biology, behavioral, and social science contexts within which they would anticipate implementing a prevention modality or multipurpose prevention modality. Since the standard of care for the foreseeable future is oral pre-exposure prophylaxis, the applicant will need to consider how the proposed modality addresses a specific public health need and would provide improvements over the current standard of care. Topical agents that provide systemic coverage and address the challenges of adherence would be acceptable.

Will non-HIV research, such as the antibacterial resistance of other infectious diseases, be implemented in Network awards?

The HIV/AIDS Clinical Trials Networks have the potential to conduct clinical trials that address additional infectious diseases including urgent or emerging pathogens. However, your applications should focus on addressing the research priority areas in the HIV/AIDS Clinical Trials Network FOAs. Once awards are made, DAIDS will consider non-HIV studies as needs arise.

What does it mean that studies of non-infectious co-morbidities will require partnerships?

HIV/AIDS research spans the missions of multiple NIH institutes. Clinical studies focused on non-infectious co-morbidities require partnerships with other NIH institutes that provide funding and staff expertise. We will address the details on what each partner will support on a protocol-specific basis.

In the “Complications and Co-infections” Research Priority Area of RFA-AI-19-004, it states “Working with NIAID and other partners, evaluate novel preventive and/or therapeutic approaches for high-priority diseases of importance to pediatric HIV-infected/affected populations such as respiratory syncytial virus (RSV) disease.” Can you please clarify the potential scope of approaches and diseases that the grantee will be responsible for addressing?

This section of the FOA has a very limited scope. It is limited to those preventive and therapeutic approaches/concepts that NIAID identifies as high priority for evaluation by the grant funded from this FOA.

(Question and answer above added on March 15, 2019.)

RFA-AI-19-005 states that products that do not achieve complete systemic protection but do address an agreed upon compelling specific public health need can be considered on a case-by-case basis if the scientific data support moving them forward to clinical testing. What is considered a “compelling public health need” and who is involved in that determination?

Many parties are involved in providing and interpreting the qualitative and quantitative data that signal changes in the HIV pandemic and resulting public health needs for HIV prevention. NIH takes all information into account to understand the dynamics of HIV risk and infection to determine public health need. In collaboration with the clinical trial network investigators, NIAID and co-funding NIH partners review concepts emanating from the clinical trials networks and determine whether they meet Institute priorities and whether or not funding is available.

(Question and answer above added on March 15, 2019.)

Is the high bar set for microbicides (i.e., the requirement to impart or confer systemic protection against HIV acquisition) also set for every prevention modality that advances to clinical testing within the network (e.g., long-acting, injections, bNAbs, vaccines)?

To be a candidate for clinical testing within the HIV Prevention Network, prevention modalities should be considered likely to be safe and effective based on preclinical data. Efficacy should compare favorably to currently approved PrEP, which is more than 90 percent effective when used correctly.

(Question and answer above added on March 15, 2019.)

Part 2, Section I of the LOC FOAs states that “The LOC will be responsible for overall administrative and scientific leadership for the network, as well as oversight and evaluation of all network activities”. Does this imply that the LOC has a formal oversight role and is responsible for directly evaluating the quality and performance of the SDMC, LC, and CTUs/CRSs? Or does it mean that the LOC will simply coordinate with the SDMC, LC, and CTUs/CRSs to achieve the goals of the network?

Like the structure used for the current NIAID awards, NIAID plans to award separate UM1 cooperative agreements for the LOC, LC, SDMC, and CTUs. As separate awards, there is no implication of direct oversight authority. However, as collaborative parts of the same Clinical Trials Network, we expect the LOC to oversee and coordinate the activities within the Network as described in the “Leadership and Operations Center Specific Responsibilities” section of the FOA. This means that the LOC must ensure the quality and performance of Network activities. In the application, it’s up to the applicant to propose a plan for how to meet these responsibilities.

(Question and answer above added on April 10, 2019.)

The LOC FOAs ask applicants to “Address quality control procedures including real time systemic checks of protocol and regulatory adherence, quality assurance including regular auditing, and quality improvement based on evaluation and education.” What is meant by “real time” systemic checks of protocol and regulatory adherence for the LOC? What type of “auditing” is expected?

Quality is integrally linked to every aspect of clinical operations from protocol inception through final reporting. “Real-time” means that adherence is periodically checked along the way and not just at the time the final study report is prepared or at the time of submission to regulatory authorities.

“Auditing” refers to both internal auditing of the LOC as well as the management of site audits. Under the Quality Management heading in the Leadership and Operations Center Specific Responsibilities section of the FOA, it says “The LOC will also be responsible for enabling sponsor/client audits and inspections by regulatory authorities.”

(Question and answer above added on April 10, 2019.)

The LOC FOAs ask applicants to “Discuss how the LOC will facilitate the use of data systems by the SDMC that are compliant with 21 CFR and ICH guidelines.” What is meant by “use of data systems by the SMDC”? Is the LOC responsible for ensuring that the SDMC data systems are compliant with 21 CFR and ICH guidelines?

In Part 2, Section I of the LOC FOAs, under the heading Structure of the Network, it states that “The SDMC will provide… state-of-the-art clinical trial management systems and laboratory information management systems to ensure complete, high-quality data.”

The LOC is responsible for “ensuring that clinical trials are conducted in compliance with 21CFR Part 11 and ICHE6R2 guidelines.” The LOC must factor in the SDMC’s use of data systems for clinical site selection and qualification.

(Question and answer above added on April 10, 2019.)

The LOC FOAs ask applicants to “Describe the process for verifying that SDMC and clinical site capacity are available and sufficient to support implementation of protocols.” By verify, do you mean a formal assessment and evaluation of capacity at the SDMC and clinical sites?

As indicated, the FOAs instruct applicants to “describe the process for verifying that SDMC and clinical site capacity are available and sufficient to support implementation of protocols.” In the application, the applicant will propose how these activities are conducted.

(Question and answer above added on April 10, 2019.)

The LOC FOAs ask applicants to “Describe how the training needs of LOC scientific staff will be determined, provided and evaluated, and how necessary changes in training will be decided and implemented.” Can you clarify the LOC’s training-related responsibilities?

Part 2, Section I of the LOCs FOAs states “The LOC is expected to provide the necessary and appropriate training for staff, and will be responsible for ensuring that training needs are met across the network, including but not limited to, protocol training for participating sites and other key stakeholders.”

This includes responsibility for training of staff at the LOC, the scientific staff included in the LOC award, and for staff across the network for topics under the LOC-specific responsibilities.

(Question and answer above added on April 10, 2019.)

In RFAs AI-19-005 (HIV Prevention LOC) and AI-19-006 (HIV Vaccines LOC) there is shared “cross-network collaborative research priority area” language specific to “passive administration of antibodies”. Can you clarify what’s meant by “polyclonal antibody mixtures derived directly from humans or from biotechnological engineering”?

This particular wording is intended to be widely-encompassing and may include mixtures of mAbs, mixtures of vector-expressed Abs, or polyclonal sera or fractions of sera.

(Question and answer above added on April 26, 2019.)

RFA AI-19-003 (Adult Therapeutics LOC) does not specifically call out neurologic complications of HIV or mental health issues as priorities, although NIMH and NINDS are listed as collaborating ICs. Will inclusion of these important co-morbidities of HIV infection as priorities in an application be considered responsive to the FOA?

As stated in the RFA, people living with HIV (PLWH) are at higher risk for developing non-AIDS associated conditions including neurological and mental health issues such as depression and anxiety. Furthermore, a better understanding of the mechanisms that underlie chronic persistence of HIV in cells and tissues and alters cellular metabolism and tissue function are very high priorities across the comorbidities, which includes the neural system.

Research proposals focused on understanding how to mitigate HIV persistence and the resultant tissue and organ dysfunction, and the development of strategies and novel therapeutic interventions for the prevention and treatment of these comorbidities, should incorporate evaluations of the neural system as appropriate.

(Question and answer above added on May 28, 2019.)

Study and Trial Issues

Must an application propose a fully developed clinical trial to be responsive to these FOAs?

No. Definite plans for fully developed clinical trials will not be possible at the time of application. You must not propose a fully developed clinical trial or complete a Study Record. Instead, you must add and complete at least one delayed onset study record in FORMS-E, as instructed in the FOAs.

For clinical trials, what information should be provided in the body of the application?

Summarize the research agenda in Sub-section C. Clinical Research Agenda of the application.

Follow the FOA-specific instructions in section IV.2 PHS Human Subjects and Clinical Trials Information and see the question immediately above about delayed onset studies.

Do I need to include a Study Record for each ongoing clinical study?

No. For renewal applications with ongoing clinical studies, follow the FOA-specific instructions listed under Other Requested Information.

The applicant instructions under “PHS Human Subjects and Clinical Trials Information” say:

Other Requested Information

For Renewal applications with ongoing clinical studies, applicants must include a list of all ongoing clinical studies and/or the unique ClinicalTrials.gov identifiers. All information must be combined in one single attachment using the file name "ongoing Clinical Studies". If appropriate, please indicate for each study the NIAID Division of AIDS (DAIDS)-defined study status (https://rsc.niaid.nih.gov/networks-protocol-teams/developing-protocols).

Would you clarify which DAIDS-defined study statuses are considered “ongoing” and the timeframe for which this information is requested?

In the “Ongoing Clinical Studies” attachment, renewal (type 2) applicants should include any ongoing clinical studies for which they anticipate continuing support will be necessary in the next funding cycle, starting in December 2020.

Studies that may be considered “ongoing” are those that are projected to be in DAIDS-defined study status “In Development” through “Participants Off Study & Primary Analysis Completed”, as outlined here: https://rsc.niaid.nih.gov/networks-protocol-teams/developing-protocols

Include clinical trials, sub-studies, and any clinical research studies that aren’t clinical trials. NIAID will work with the grantees at the time of award to make changes to this list as necessary.

(Question and answer above added on July 16, 2019.)

Do I need to provide a single IRB plan in the application?

No. Follow the instructions for delayed onset studies for how you will comply with NIH's Single Institutional Review Board (sIRB) Policy.

There seems to be an emphasis on Quality Management. Do applicants need to name a key person to be a quality manager?

Clinical research quality is integrated and embedded in every aspect of the clinical trial process. The quality management framework includes planning before the trial, adequate oversight and monitoring during the trial, and verification to ensure accurate reporting of results at the conclusion of the trial to ensure adherence to the study protocol, regulatory requirements, and GCP standards in conducting the trial.

Large clinical trial efforts present additional challenges in multi-organizational coordination, including changes and variation between local and international regulatory requirements and standards. The FOAs emphasize the need for integrated Quality Management Plans to define, coordinate, and monitor all trial-related activities and to provide clear designation of responsibilities among awardees. To anticipate, prevent, and address protocol, regulatory, and/or GCP non-compliance issues, should they arise, a risk management framework considers all parts of the process, includes controls, and then tests the strength of the controls.

While the FOAs do not mandate a quality manager as key personnel, the staffing plan must address personnel needed to achieve the quality management requirements stated in the FOAs.

There seems to be an emphasis on investigational product licensure, can you provide more clarification?

The emphasis is on ensuring that DAIDS’ trials are conducted in accordance with applicable regulations and guidelines, including but not limited to the Code of Federal Regulations and International Code of Harmonization Good Clinical Practice (ICH GCP), and that quality-focused processes are established and managed in the conduct of the trials.

Do applicants need to describe capacity to ensure all sponsor-delegated regulatory responsibilities are met?

Applicants need to demonstrate that they understand all applicable regulatory requirements, provide a plan to meet any regulatory requirements for clinical trials they participate in and describe the process to document, implement, and oversee regulatory requirements during the conduct of the trials.

For clinical trials, can you clarify what you expect the grantee to provide and what support services NIAID will provide?

Refer to Additional Resources Provided by NIAID for descriptions of NIAID services that may be available. The specific clinical support services NIAID will provide for each trial will be determined in consultation with NIAID DAIDS and other collaborating IC staff during protocol development and prior to approval of the final protocol.

Generally, NIAID will convene the safety oversight committee (Data and Safety Monitoring Board) for clinical trials that require this level of data and safety monitoring, and NIAID Medical Officers will be responsible for the disposition of Serious Adverse Events for all network clinical trials. Funds for a DSMB or SAE disposition should not be requested in the budget.

NIAID may provide support services including IND/IDE regulatory sponsorship, pharmaceutical support, and clinical site monitoring. When NIAID is not the regulatory sponsor, clinical monitoring support and pharmaceutical support is provided based on a case-by-case determination. In the application budget, do not request funds for services such as regulatory support, pharmaceutical support, and clinical site monitoring that NIAID provides.

Who will decide whether proposed clinical trials should be conducted under an IND/IDE?

NIAID DAIDS reserves the right to determine whether individual clinical trials must be conducted under an IND/IDE. Generally, this decision and designation of the regulatory sponsor is made in consultation with the LOC before protocol development begins. Ultimately, the FDA will determine whether the clinical trial must be conducted under an IND/IDE.

Is a standard data-management platform required to participate in Network research?

The FOAs for Statistical and Data Management Centers (SDMCs) and Laboratory Centers (LCs) describe the requirements for clinical data management systems to support clinical trials in compliance with 21 CFR Part 11 and ICHE6R2 and other regulations in a cost-effective manner. Fully validated systems are required. For more information see the DAIDS electronic data policy.

In RFA AI-19-002 (SDMCs), under subsection B of the Research Plan instructions (“Data Collection and Management”) it has the following two bullets:

  • an Interactive Response Technology (IRT) System for subject registration and randomization
  • a laboratory information management system that integrates with IRT to manage study specimens in real time, for use by the SDMC, study sites, laboratories and others.

Can you clarify whether the “IRT” in these two bullet points is meant to be the same IRT? In other words, is there an expectation that the IRT that is used for randomization/registration is the same IRT that is used for specimen management?

The second bullet is asking for capability for integration between the laboratory information management system (LIMS) system and participant information. This may be via the same IRT system used for registration and randomization or via another system (e.g., electronic data capture system). If the applicant doesn’t have integration via the IRT, they may describe other systems that provide this integration.

(Question and answer above added on May 28, 2019.)

Peer Review

The FOA-specific instructions say not to include a clinical trial but a number of review criteria address specific trials. Can you clarify?

The NIH standard review criteria are included in every NIH FOA and are followed by FOA-specific instructions and review criteria. Reviewers will be instructed to assess applications based on specific instructions and review criteria that apply for each FOA.

Does NIAID plan to include a site visit or reverse site visit as part of the peer review process?

No.

The research strategy section for the LOC FOAs requires 11 sub-sections. Will each of these sub-sections receive a separate Overall Impact Score?

No. The LOC application will receive one Overall Impact score for the entire application.

To whom should I send the Letter of Intent?

The letter of intent should be sent to the Scientific Review Officer (SRO) listed under Section IV of the Funding Opportunity Announcement (FOA).

Who do I contact for questions about peer review of my application?

Please contact the SRO listed under Section VII (Peer Review Contact) of the FOA.

Will I be able to submit additional documents after the application submission deadline?

Applicants are required to follow the instructions for post-submission materials, as described in the Post-Submission Materials Policy. Please contact the SRO for additional information.

How will peer review be conducted for LOC, LC and SDMC applications that are submitted for the same HIV/AIDS Clinical Trials Network?

We anticipate that NIAID will conduct six separate peer review meetings – one for each of the six published FOAs (RFAs AI-19-001, AI-19-002, AI-19-003, AI-19-004, AI-19-005 and AI-19-006). Each LOC, LC and SDMC application will need to be complete in itself. Reviewers will only be able to view applications received in response to the specific FOA assigned to their scientific review group. For example, reviewers evaluating a LOC application will not have access to the LC or SDMC applications associated with the same HIV/AIDS Clinical Trials Network.

(Question and answer above added on April 26, 2019.)

Contact Information

Whom do I contact for more information about these FOAs?

Find NIH scientific/research, peer review, and financial/grants management contacts listed in each of the FOAs. You may submit any general questions about these FOAs to NIAIDNetworkRefinement@mail.nih.gov.

Please include your name, email address, institution, and FOA(s) you are inquiring about.

Content last reviewed on